Comparison study of combined Diclofenac NA and hydrocortisone versus Diclofenac or hydrocortisone on shivering and pain during cesarean section under spinal anesthesia
The aim of this study is the comparison of combined Diclofenac NA suppository and intravenous hydrocortisone versus with Diclofenac NA suppository or intravenous hydrocortisone on shivering and pain during cesarean section surgery. It is a double-blind randomized clinical trial study on 150 women who were candidate for elective cesarean. Inclusion criteria: pregnant women who candidate for elective cesarean section; ASA class 1, 2. Exclusion criteria: history of asthma; peptic ulcer; febrile disease, or endocrine disease; addiction to opioid; smoking; consumption of steroids; consumption of NSAIDS or other analgesics. First group received Diclofenac NA suppository and normal saline, second group received intravenous Hydrocortisone and placebo suppository and third group received intravenous Hydrocortisone and Diclofenac NA suppository. Thermometry from tympanic membrane was done 10 min before anesthesia, after surgery and every 30 minute until an hour. Pain severity is classified in numerical scale in 24 hours and analgesic administered if needed and the earliest time that analgesic administered and total dose of analgesic in 24 hours compare with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041317136N2
Registration date:2014-06-12, 1393/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-12, 1393/03/22
Registrant information
Name
Seyed Ali Hosseini
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3368 3980
Email address
sahoseini@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Qazvin University of Medical Science and Health Services
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison study of combined Diclofenac NA and hydrocortisone versus Diclofenac or hydrocortisone on shivering and pain during cesarean section under spinal anesthesia
Public title
Comparison study of combined Diclofenac NA and hydrocortisone versus Diclofenac or hydrocortisone on shivering and pain during cesarean section under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women who candidate for elective cesarean section; ASA class 1, 2. Exclusion criteria: history of asthma; peptic ulcer; febrile disease, or endocrine disease; addiction to opioid; smoking; consumption of steroids; consumption of NSAIDS or other analgesics.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin university of medical science
Street address
Shahid Bahonar Blv
City
Qazvin
Postal code
3418899581
Approval date
2013-11-25, 1392/09/04
Ethics committee reference number
28/20/8104
Health conditions studied
1
Description of health condition studied
Complications predominantly related to the puerperium
ICD-10 code
089.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during the puerperium
Primary outcomes
1
Description
Shivering
Timepoint
10 min before anesthesia, after surgery and every 30 minute until an hour.
Method of measurement
Vision and medical records
2
Description
Pain
Timepoint
Until 24 hours post operation
Method of measurement
The first time and the total dose of analgesic administered
Secondary outcomes
1
Description
Temperature
Timepoint
10 min before anesthesia, after surgery and every 30 minute until an hour
Method of measurement
Thermometery from tympanic membrane
2
Description
Blood pressure
Timepoint
10 min before anesthesia, after surgery and every 30 minute until an hour
Method of measurement
With manonetery from brachial artery
3
Description
Pulse rate
Timepoint
10 min before anesthesia, after surgery and every 30 minute until an hour
Method of measurement
With monitoring
Intervention groups
1
Description
Second group received plasebo Supp. and 2cc of IV hydrocortison
Category
Treatment - Drugs
2
Description
First group received 100mg Diclofenac supp and 2cc of normal saline
Category
Treatment - Drugs
3
Description
Third group received 100 mg diclofenac Supp. and 2cc of IV hydrocortison
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Dr. Marzieh Beigom Khezri
Street address
Taleghani street,Kosar Hospital
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Qazvin University of Medical Science and Health Services
Full name of responsible person
Dr Saeed Assefzadeh
Street address
Shahid Bahonar Blvd
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Qazvin University of Medical Science and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kosar Hospital
Full name of responsible person
Dr. Marzieh Beigom Khezri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Taleghani street
City
Qazvin
Postal code
3418899581
Phone
+98 28 3222 2452
Fax
Email
mkhezri@qums.ac.ir; sahoseine@qums.ac.ir
Web page address
qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kosar Hospital
Full name of responsible person
Dr. Marzieh Beigom Khezri
Position
Anesthesiologist/assistant professer
Other areas of specialty/work
Street address
Taleghani street,Kosar Hospital
City
Qazvin
Postal code
3418899581
Phone
+98 28 3222 2452
Fax
Email
mkhezri@qums.ac.ir,sahoseini@qums.ac.ir
Web page address
www.qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kosar Hospital
Full name of responsible person
Dr. Marzieh Beigom Khezri
Position
Anestesiologist/assistant professer
Other areas of specialty/work
Street address
Taleghani Street,Kosar Hospital
City
Qazvin
Postal code
3418899581
Phone
+98 28 3222 2452
Fax
Email
mkhezri@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)